Low Dose Valganciclovir Prophylaxis Following Renal Transplantation With Steroid Free Immunosuppression

J. Chen,¹ A. Shah,² M. Sauer,¹ T. Taber,³ A. Sharfuddin,³ M. Yaqub,³ D. Mishler,³ J. Powelson,⁴ W. Goggins.⁴

¹Pharmacy, IU Health, Indianapolis
²Surgery, Thomas Jefferson University, Philadelphia
³Nephrology, Indiana University School of Medicine, Indianapolis
⁴Surgery, Indiana University School of Medicine, Indianapolis.

Meeting: 2015 American Transplant Congress

Abstract number: D266

Keywords: Cytomeglovirus, Kidney transplantation, Prophylaxis

Session Information

Session Name: Poster Session D: Viral Infections

Session Type: Poster Session

Date: Tuesday, May 5, 2015

Session Time: 5:30pm-6:30pm

Presentation Time: 5:30pm-6:30pm

Location: Exhibit Hall E

AST ID guidelines recommend a valganciclovir (VGCV) prophylaxis dose of 900 mg daily for patients with CrCL > 60 mL/min with reduced dose for renal dysfunction. VGCV is the most expensive transplant medication required. This retrospective study investigated the efficacy, safety, and cost savings of using a low dose VGCV prophylaxis regimen.

The records of 354 renal transplant recipients with at least 1 year follow-up were reviewed. Immunosuppression included rabbit anti-thymocyte globulin (6 mg/kg) induction, rapid steroid withdrawal and maintenance therapy of tacrolimus and mycophenolate. VGCV prophylaxis started on postop day 2: 450 mg daily for CrCl > 40 mL/min and 450 mg every other daily for CrCl < 40 mL/min. Of 251 subjects with CrCl > 40 mL/min, 125 had CrCl > 60 mL/min.

The 125 patients were stratified by CMV risk: 28 Donor (D) +/ Recipient (R) -, 43 D+/R+, 24 D-/R+ and 30 D-/R-. Overall CMV infection rate was 2.4% in this group. CMV rates by group were observed: 3.5% in the D+/R- group, 2.2% in the D+/R+ group, 0% in the D-/R+ group, and 3.3% in the D-/R- group. Overall 1 year rejection rate in this group was 16.3%, one year graft survival 96.8%, and patient survival 98.4%. This compares to a 1 year rejection rate of 16.8%, graft survival rate of 98%, and patient survival rate of 98.5% in the entire 354 patient population. No increased incidence of rejection associated with CMV infection was observed. One D +/R- patient developed CMV colitis/pneumonitis 4 months after transplant while taking VGCV prophylaxis. The patient was treated with IV ganciclovir, switched to foscarnet and subsequently died from CMV infection.

Low dose VGCV prophylaxis is associated with substantial cost savings. Using Average Wholesale Price, cost per patient for high risk (D+/R-) is $27,816 for 900 mg/day for 6 months versus $13,908 for 450 mg/day. For all other patients, the difference in per patient cost is $4,636 for 900 mg/day for 3 months versus $2,318 for 450 mg/day.

In our 125 patients, low dose VGCV prophylaxis was successfully used. There was no increased CMV infection, rejection, graft loss or patient loss with low dose VGCV. Low dose VGCV can be used to prevent early CMV infection without an increase in adverse events.

To cite this abstract in AMA style:

Chen J, Shah A, Sauer M, Taber T, Sharfuddin A, Yaqub M, Mishler D, Powelson J, Goggins W. Low Dose Valganciclovir Prophylaxis Following Renal Transplantation With Steroid Free Immunosuppression [abstract]. Am J Transplant. 2015; 15 (suppl 3). https://atcmeetingabstracts.com/abstract/low-dose-valganciclovir-prophylaxis-following-renal-transplantation-with-steroid-free-immunosuppression/. Accessed May 17, 2025.

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